Kornimate/medical-research-clean huggingface dataset:
application of hyaluronic acid in the treatment of periodontitis

Conditions: Periodontal Bone Loss

Summary: the aim of the present investigation will be evaluated the healing of suprabony defects following surgical flap elevation and hyaluronic acid application respect to surgical flap elevation alone. a total of 80 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group and no-hyaluronic acid group.

the objective of the study will be compare the healing of suprabony defects following treatment with either open flap debridement (ofd) and application of hyaluronic acid (ha) with ofd alone. eighty patients with suprabony periodontal defects will be randomly assigned to treatment with open flap debridement and application of hyaluronic acid (ha group) or open flap debridement alone (no-ha group). primary outcome will be clinical attachment level (cal) gain, while the secondary outcomes will be probing depth (pd) and gingival recession (gr). after local anesthesia, an access flap will be prepared. depending on the mesiodistal width of the interproximal space, two different incision techniques will be selected to access the suprabony defect area. the modified papilla preservation technique (mmpt) will be used at sites with an interproximal width \> 2 mm, whereas the simplified papilla preservation technique (sppt) will be applied at sites with an interproximal width ≤ 2 mm. then, a mucoperiosteal flap will be reflected. scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler. hyaluronic acid will be applied to exposed roots surface only in ha group followed, for both groups, by a tension-free primary closure of the interdental papillae and of the mucoperiostal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.

Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis * age ≥ 18 years old * single-rooted and multi-rooted teeth * presence of suprabony periodontal defects at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth in either the maxilla or the mandible with a pd ≥ 5 mm after completion of non-surgical periodontal treatment and re-evaluation * intrabony defect with an intraosseous component \< 2 mm exclusion criteria: * patients with systemic diseases * prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to surgery * pregnant or lactating * tobacco smokers (≥ 10 cigarettes per day) * multi-rooted teeth with furcation involvement * increased tooth mobility (grade ii and iii)

Keywords: hyaluronic acid suprabony defect surgical periodontal therapy periodontal bone loss
brachiocephalic arteriovenous fistulae: two different techniques of bloodless surgery and their effect on fistula stenosis.

Conditions: Arteriovenous Fistula; Tourniquet; Stenosis

Summary: patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. the autologous arteriovenous fistula (avf) is recognized as the golden standard of dialysis access. unfortunately a great number of the avfs fail to mature, and therefore cannot be used for dialysis. a significant stenosis is a major cause of nonmaturing avfs. remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. the primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic avf.

patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. the autologous arteriovenous fistula (avf) is the golden standard of dialysis access. unfortunately a great number of the avfs fail to mature, and therefore cannot be used for dialysis. a significant stenosis is a major cause of nonmaturing avfs. remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. the primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic avf.

Eligibility criteria:
inclusion criteria: * mentally competent * written informed consent * age 18 years and older * indication for brachiocephalic avf in hagaziekenhuis * patient is able to complete the follow-up evaluation exclusion criteria: * pregnancy
direct endomyocardial injection of autologous bone marrow cells to treat ischaemic heart failure

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure.

coronary artery disease (cad) remains to be one of the leading causes of mortality and morbidity worldwide. despite the optimal use of anti-anginal medications and coronary revascularization, a large number of patients with cad suffer from severe symptoms with disabling angina and heart failure (hf). experimental and pilot clinical studies provided evidence of the safety and potential efficacy of a strategy of intramyocardial transplantation of autologous bone marrow (bm) cells for neovascularisation of chronically ischemic myocardium. nevertheless, the possible potent placebo effect on symptoms observed in these pilot studies highlights the need for a randomized, placebo-controlled group to prove the clinical efficacy of cell based angiogenic therapy for treatment of severe cad.

Eligibility criteria:
inclusion criteria: * age 18-80 years old * canadian cardiovascular (cv) class ii-iv angina and/or nyha class ii-iii hf symptoms * received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms. * not suitable for conventional revascularization by their referring cardiologist. * lvef \<40% by echocardiography. * recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of cad that is not amenable to standard revascularization procedures. * creatinine less than 250mmol/l, normal liver function, and normal blood count: wbc, granulocytes; platelet count, hb. * reversible perfusion defect on single photon emission computed tomography (spect) * able to walk on treadmill * hemodynamically stable * subject is willing to comply with specified follow-up evaluations. * all patients give written informed consent. exclusion criteria: * atrial fibrillation * history of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation * severe valve disease * aortic or mitral valve prosthesis * history of cancer in last 5 years * acute or chronic active sepsis, including hiv positive; hepatitis b or c positive * left ventricular wall thickness less than 8 mm in the target territory * left ventricular thrombus and/or spontaneous echo-contrast in the lv detected by echocardiography or lv aneurysm * severe aorto-femoral-iliac disease * recent heart attack within the last 30 days * hypertrophic or restrictive cardiomyopathy * severe co-morbidity associated with a reduction in life expectancy of less than 1 year

Keywords: end-hf
naproxen for acute pain after surgery: a randomized, placebo-controlled trial

Conditions: Pain, Postoperative

Summary: the purpose of this study is to determine whether using an additional 48 hours of oral naproxen, after other post-operative pain medications have been stopped, will be effective in reducing opiate pain medication requirements and contribute to improved pain management.

at st. joseph's healthcare hamilton, the acute pain service (aps) is responsible for the immediate post-operative pain management of many surgical inpatients. while cared for by aps, the patient receives multimodal analgesia, including adjunctive medications (acetaminophen and naproxen/ketorolac) scheduled around the clock. when aps discontinues the epidural/pain pump, all adjunctive medications are discontinued and the patient is usually started on 'as needed' opiate or combination opiate (i.e. tylenol#3) medications. on occasion, aps will write an order for an additional 48 hours of naproxen, but this practice has not been formally evaluated at this site. this randomized, placebo-controlled study proposes to evaluate this bridging strategy to see if regularly scheduled naproxen after discontinuation of other post-operative medications will affect the daily doses of opiate pain medications used, side effects of those opiate medications and pain scores of patients.

Eligibility criteria:
inclusion criteria: * undergone head \& neck and thoracic surgery * admitted to chest, head and neck or step-down at st. joseph's healthcare * pain management by aps (epidural/pain pump) including naproxen/ketorolac * able to take oral medications (by mouth, feeding tube or ng tube) * reasonably able to communicate in english and provide consent exclusion criteria: * pre-existing chronic pain (morphine equivalent doses over 200mg/day in 5 days previous to surgery) * recovering from cardiac, urological, orthopedic, laparoscopic or ambulatory surgery * chronic nsaid therapy (daily for more than 3 weeks or high dose (over 81mg) asa at least 4 days/week for more than 3 weeks) * pregnancy, diagnosis of sepsis, history of stroke or transient ischemic attack, chf (nyha 3 or 4), allergy or contraindication to nsaids as defined by aps protocol

Keywords: naproxen acute pain postoperative pain thoracic surgery head and neck surgery opiate sparing
magnevist® injection enhanced mra compared to non contrast mra for the detection of stenosis in the calf and/or pedal arteries

Conditions: Stenosis

Summary: the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of magnevist (the study drug) used for mri of the calf and foot arteries. the results will be compared to the results of mri taken without magnevist, and with the results of your x-ray angiography.

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc.is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * has known or suspected disease of the calf and/or pedal arteries * is scheduled for x-ray angiography exclusion criteria: * has any contraindication to magnetic resonance imaging * is scheduled for any procedure before the x-ray angiography * had previously had stents placed bilaterally in the calf and/or foot arteries

Keywords: stenosis of the calf and/or pedal arteries
safety and efficacy study of hypofractionated radiotherapy and androgen deprivation therapy for prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (padt).

primary endpoints: * acute gastrointestinal (gi) and genitourinary (gu) common terminology criteria for adverse events (ctcae) v3.0 toxicities secondary endpoints: * late gi and gu radiation therapy oncology group (rtog) toxicities * biochemical disease-free survival * biopsy positive rate at 3 years * quality of life using the expanded prostate cancer index composite (epic) questionnaire * develop a biobank of dna and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity

Eligibility criteria:
inclusion criteria: * informed consent obtained * men \> 18 years * histologically confirmed prostate adenocarcinoma (centrally reviewed) * high risk prostate cancer, defined as at least one of: clinical stage t3, or gleason score 8-10, or psa \> 20ng/ml exclusion criteria: * prior pelvic radiotherapy * anticoagulation medication (if unsafe to discontinue for gold seed insertion) * diagnosis of bleeding diathesis * pelvic girth \> 40cm (to ensure visibility of gold seeds on electronic portal imaging) * large prostate (\> 90cm3) on imaging * severe lower urinary tract symptoms (international prostate symptom score \>19 or nocturia \> 3) * no evidence of castrate resistance (defined as psa \< 3ng/ml while testosterone is \< 0.7nmol/l). patients could have been on combined androgen blockade but are excluded if this was started due to psa progression

Keywords: prostatic neoplasms radiotherapy hypofractionated high risk prostate cancer
attend-family-led rehabilitation after stroke in india

Conditions: Stroke

Summary: attend trial is based on early supported discharge- home based stroke rehabilitation model which proves to offer several advantages in low and mid income countries. the objectives of the pilot stude were to determine that with a randomized blinded outcome assessor, controlled trial, family- led caregiver- delivered home based rehabilitation is better than usual care for those with disabling stroke in india and the feasibility of this model.


Eligibility criteria:
inclusion criteria: * adults (\>18 years) * recent (\<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke * residual disability (requiring help from another person for everyday activities) * expected to survive to discharge from hospital with a reasonable expectation of six month survival * able (or by proxy) to provide informed consent exclusion criteria: * unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care * those unwilling/unable to adhere to follow up.
comparing the nautilus neurowavetm to tcd or dsa for the detection of vasospasm

Conditions: Vasospasm

Summary: to determine the efficacy of using the jan medical nnw system as a diagnostic aid in detection of moderate and severe vasospasm for detection of vasospasm in patients with subarachnoid hemorrhage.

this study is a prospective, comparative, non-randomized study in subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm. the study will be conducted in one center. the primary objective of phase i of this non-significant risk study is proof of principle. during this phase the goal is to build a library of jan medical nnw system recordings from patients with moderate and severe vasospasms. a signature for detecting vasospasms will be developed using the signals from a vasospasm epoch to a patient's individual baseline recording and confirming the presence of vasospasm by comparison of jan medical nnw system data to tcd and, when available digital subtraction angiography (dsa). the number of patients required for phase i is estimated to be 20 patients with confirmed moderate or severe vasospasm with a minimum of 10 these patients having at least one severe vasospasm recording confirmed by tcd or dsa. daily recordings are to be taken. during phase ii the jan medical nnw system will independently utilize the signatures identified in phase i to identify the presence or absence of moderate and severe vasospasm in a blinded recording. this recording will be compared to tcd or dsa, when dsa is available, for analysis of sensitivity and specificity. up to 50 subjects will be enrolled in phase ii. when possible, multiple recordings will be obtained from each subject to include recordings with and without vasospasm. duration of each subject's enrollment in this study is limited to the period of time when jan medical nnw system recordings are performed. no additional tests or procedures will be performed during participation in this study and all other data collected (including tcd or dsa) will be based on available evaluations conducted as part of the patient's standard of care. upon completing the last jan medical nnw system recording or when no further data collection is expected, the subject will be exited from the study.

Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 years of age or older. 2. subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm. 3. signed informed consent from the patient or the patient's legally authorized representative exclusion criteria: 1. unstable medical illness such that recordings might interfere with medical care. 2. presence of head bandages or brain monitors that might physically interfere with the nnw recording device. 3. current hemicraniectomy.

Keywords: vasospasm aneurysm sah nautilus neurowave
oxcarbazepine for the treatment of chronic peripheral neuropathic pain

Conditions: Polyneuropathy; Peripheral Nerve Injury; Postherpetic Neuralgia

Summary: the purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * definite or probable neuropathic pain * diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju * pain duration \> 3 months * pain rating at baseline \>= 4 point nrs * informed consent exclusion criteria: * other non-neuropathic pain condition * allergy to oxcarbazepine * renal or hepatic impairment * epilepsy * depression and other serious psychiatric disorders * serious medical condition * previous treatment for neuropathic that cannot be stopped * pregnancy * patients expected not to be able to comply with study protocol * treatment with anticonvulsants, antidepressant or opioids

Keywords: neuropathic pain oxcarbazepine pain mechanism
exploring the efficacy and feasibility of the lymphatech scanner for breast cancer-related lymphedema screening

Conditions: Breast Cancer

Summary: this research will compare the absolute volumes of the upper extremity using both the lymphatech scanner and perometer in a cohort of patients with a history of invasive or in-situ carcinoma of the breast.

our trial seeks to assess the efficacy of the lymphatech scanner as compared to the perometer, which is currently used to screen for breast cancer-related lymphedema. the focus of the study is to compare the absolute volumes of the upper-extremity as measured by each device and to compare the time it takes to measure both arms of a patient using each device to assess clinical feasibility.

Eligibility criteria:
inclusion criteria: * participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast and will undergo unilateral breast cancer surgery * age \>18 years. * ability to understand and the willingness to verbally consent to the trial exclusion criteria: * history of primary lymphedema. * any patient with a current case of cellulitis. * participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * participants unable to abduct upper-extremity perpendicular to body or to stand comfortably without aid for several minutes, both of which are necessary to perform a lymphatech scan

Keywords: breast cancer
study of oral ubrogepant to assess adverse events and change in disease activity in adult participants with menstrual migraine

Conditions: Migraine

Summary: a migraine is a moderate to severe headache typically on one side of the head. a migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. menstrual migraine (mm) is defined as migraine attacks that occur within the perimenstrual period (pmp) in at least 2 out of 3 menstrual cycles. the pmp is from 2 days before the onset of menstrual bleeding to 2 days after. this study will assess how safe and effective ubrogepant is in treating menstrual migraine. adverse events and change in disease activity will be assessed. ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. around 450 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the united states and puerto rico. participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 pmps during double-blind period (16 weeks). eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks). there may be higher treatment burden for participants in this trial compared to their standard of care. participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * at least a 1-year history of migraine with or without aura. * have experienced migraine attacks in at least 2 of 3 perimenstrual periods (pmps) during the screening period. * collection of daily ediary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (mm) diagnosis. * have regular menstrual cycles of between 21-35 days in length. * less than 15 headache days per month. * at least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening pmp. exclusion criteria: * history of migraine with brainstem aura, hemiplegic migraine, or retinal migraine. * clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion. * clinically significant abnormalities in the physical examination as determined by the investigator. * clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion. * acute headache medication overuse.

Keywords: migraine menstrual migraine ubrogepant ubrelvy
a study with gemcitabine, cisplatin, and ly293111 in non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine the effectiveness and side effects of ly293111 given in combination with gemcitabine and cisplatin in patients with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer, stage iiib or iv that is not amenable to either surgery of curative intent or radiation therapy * tumor that can be measured by x-ray or scan * adequate organ function exclusion criteria: * inability to swallow capsules * documented brain metastases * prior chemotherapy or biological therapy for this disease